21 CFR 892.1980 — Table, Radiographic, Stationary Top
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1980
Identification
A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | 2 | 27 | |
| IXR | Table, Radiographic, Tilting | 2 | 77 | |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 2 | 29 | |
| KXJ | Table, Radiologic | 2 | 31 |
Special Controls
IXQ — Table, Radiographic, Stationary Top
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
eCFR
IXR — Table, Radiographic, Tilting
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
eCFR
IZZ — Table, Radiographic, Non-Tilting, Powered
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
eCFR
KXJ — Table, Radiologic
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
eCFR
